14F7 in chronic B-cell lymphoproliferative syndrome
- Conditions
- on-Hodgkin lymphoma, Chronic lymphocytic leukemia, Multiple myeloma
- Registration Number
- RPCEC00000266
- Lead Sponsor
- Center of Molecular Immunology (CIM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 142
1. Refractory or relapsing B-cell cell lymphoproliferative syndrome, ganglioside NGlicolilGM3 (NGGM3) positive.
2. Age =18 years, any gender and race.
3. ECOG = 3.
4. Life expectancy of 6 months.
5. No candidates for transplant of hematopoietic progenitors or immunochemotherapy schemes not previously used.
6. Four or more weeks from the previous specific therapy (QT, RT, biological therapies) (applicable to patients’ refractory to the previous treatment).
7. Patients with laboratory parameters as detailed below: Hemoglobin = 80 g / L, Absolute neutrophil count = 1.5 x 109 / L, Platelet count = 75 x 109 / L, Liver function (bilirubin, ASAT or ALAT = 2.5 times the normal reference range of each institution), Renal function preserved (creatinine clearance =45 mL / min according to the Cockcroft and Gault formula).
8. Voluntary signature of the informed consent model.
9. Subjects of childbearing age and sexually active should agree to use a method of contraception during treatment (criteria valid only for patients of childbearing age).
1. Pregnant, puerperal or breastfeeding
2. Cytopenia of uncontrolled immune cause
3. Active infection or known positivity for HIV, hepatitis B or C virus
4. Heart failure grade III / IV according to NYHA criteria (New York Heart Association)
5. Chronic decompensated diseases such as: arterial hypertension, diabetes mellitus, ischemic cardiopathy or other symptomatic cardiovascular diseases, epilepsy, obstructive pulmonary disease.
6. Acute allergic states or known hypersensitivity to any component of the formulation under study.
7. Obvious mental disability or other limitation that prevents the patient from signing their consent or hinders the evaluation of the study.
8. Being receiving another research product.
9. Another clinically active neoplasm that needs specific treatment (except basal cell carcinomas or cutaneous carcinomas in situ).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stage I<br>Serious Adverse Events (SAE) with causality relationship (Serious Adverse Events those that: 1. Produce death, 2. life-threatening, 3. hospitalization or prolongation of hospitalization indicated, 4. Produce disability / persistent or significant disability, 5. Produce birth defect or congenital anomaly. Will be consider causality relationship when the SAE has definitive/highly probable or probable causality relationship). Measuring time: during and after each administration, throughout the study period until week 52.<br>Stage II<br>Objective response (Complete response y partial response according to the international criteria for each chronic B-cell lymphoproliferative syndrome). Measurement time: weeks 13, 29, 41 and 52
- Secondary Outcome Measures
Name Time Method